RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with HIV.

PURPOSE: This clinical trial is studying how well giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Impact of treatment on immune response, in terms of the difference between cytotoxic T-lymphocyte effector frequency, as measured by enzyme-linked immunospot (ELISPOT) at baseline and at week 20 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effects of treatment on viral load [ Designated as safety issue: No ]

Sequencing of any resultant HIV strains [ Designated as safety issue: No ]

CD4 counts for assessment of effects on HIV disease [ Designated as safety issue: No ]

Assess the safety of vaccination comprising E1M184V peptide with incomplete Freund's adjuvant in combination with sargramostim (GM-CSF) in patients with HIV who are HLA-A2 positive.

Assess, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic T-cell response, defined by ELISPOT assay, in these patients.

Secondary

Explore, preliminarily, the effect of this regimen on HIV viral load and CD4 count in these patients.

Explore, preliminarily, the development of lamivudine or emtricitabine resistance in patients who subsequently receive lamivudine or emtricitabine.

Explore, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic T-cell response as assessed by HLA-A2 class I tetramers and intracellular interferon gamma production after stimulation with E1M184V.

OUTLINE: This is a pilot study.

Patients receive vaccination comprising E1M184V peptide and incomplete Freund's adjuvant subcutaneously (SC) on day 1 in weeks 0, 4, 8, 12, and 16. Patients also receive sargramostim (GM-CSF) SC immediately after vaccination and once daily on days 1-4. Some patients do not receive GM-CSF after the first 2 doses of vaccine. Treatment continues in the absence of unacceptable toxicity.

Patients undergo blood collection at baseline and at 4, 12, 20, 36, and 52 weeks for biomarker/laboratory analysis. Assays may include immunoenzyme techniques and viral genotyping.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

HIV-1 infection confirmed by Western blot and enzyme-linked immunosorbent assay

Must be receiving stable regimen of highly active antiretroviral therapy (HAART) that does not include lamivudine or emtricitabine for ≥ 1 month prior to study entry

Patients on HAART, including lamivudine or emtricitabine, for which there is a medically appropriate regimen that does not include lamivudine or emtricitabine, are eligible if willing to change antiretrovirals

No other abnormality that would be scored as ≥ grade 3 toxicity, except any of the following (if asymptomatic):

Hyperuricemia of grade 4 (without physiologic consequences)

Elevation of lactate dehydrogenase ≥ grade 3

Elevation of creatine phosphokinase (CPK) ≥ grade 3

Hypophosphatemia ≥ grade 3 (if patient is on tenofovir)

Elevation of alkaline phosphate of grade 3

Hyperamylasemia of ≥ grade 3 allowed if any of the following criteria are met:

Macroamylasemia

Lipase ≤ 2 times ULN

Lymphopenia grade 3

No other condition that, in the opinion of the investigator, would preclude compliance with study requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No systemic corticosteroids within the past 3 weeks

Concurrent systemic corticosteroids allowed in the short term only

Physiologic replacement doses of steroids allowed

No prior vaccination with a vaccine that includes all or part of the reverse transcriptase of HIV-1

No other concurrent investigational drugs or vaccinations

No concurrent lamivudine or emtricitabine

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381875